Premedication with cyclooxygenase-2 inhibitor meloxicam reduced postoperative pain in patients after oral surgery.

The efficacy of the selective cyclooxygenase-2 (COX-2) inhibitor meloxicam for treatment of postoperative oral surgical pain was assessed in a randomized controlled trial. Patients undergoing unilateral mandibular 3rd molar extraction surgery were allocated to 3 groups, A, B and C. After oral premedication of meloxicam 10 mg in group A, ampiroxicam 27 mg in group B and placebo in group C, surgery was completed within 30 min under local anaesthesia using 2% lidocaine. For postoperative pain relief the patients were allowed to take oral loxoprofen (60 mg per tablet). Postoperative pain was evaluated at the clinic on the 1st, 7th and 14th postoperative day (POD) using a visual analogue scale (VAS), as was the number of loxoprofen tablets consumed, and the results were compared among the 3 groups with statistical significance of P<0.05. VAS scores on 1 POD were significantly lower in group A than in group C. Loxoprofen consumption on the day of surgery and 1 POD was significantly lower in group A than in group C (P<0.01). Total analgesic consumption was significantly lower in groups A and B than in group C (P<0.02). The COX-2 inhibitor, meloxicam 10 mg used for premedication reduced postoperative pain compared with control in oral surgery.

[Clinical studies of long acting amoxicillin in oral surgery].

Clinical studies with long acting amoxicillin (L-AMPC) have been carried out and the following results were obtained. 1. Forty-two patients with acute bacterial infections in the oral region were administrated orally L-AMPC at a daily dose of 1 gram. The clinical results obtained were classified as excellent in 3 cases, good in 28 cases, and the overall efficacy was 75.6%. 2. The antibacterial activity of AMPC was determined for 66 strains isolated from patients with oral infections. Of the strains tested, Gram positive cocci showed high sensitivity with MIC's less than 1.56 mcg/ml, while the sensitivity of PC resistance strains of S. aureus, K. pneumoniae and P. vulgaris was lower. 3. There was 1 case of transaminase elevation in the laboratory finding. 4. Five patients reported the following side effects, eruption 3, diarrhea 2, nausea 1, anorexia 1 and malaise 1. From the results of the present study, it is considered that L-AMPC is a useful antibiotic in the treatment of acute bacterial infections in oral region.

[The comparison of blood levels between peripheral vein and tooth extraction wound after the oral administration of antibiotics (author's transl)].

The oral administration of 300 mg of clindamycin was undertaken on 23 patients, of 500 mg of cefadroxil on 11 patients and of 250 mg of talampicillin on 12 patients, and then tooth extraction was performed under local anesthesia. Blood samples were taken from the extraction wound and the peripheral vein at the same time and assayed by the bioassay method. The blood levels of clindamycin and cefadroxil indicated a similar pattern between the extraction wound and the peripheral vein, but the blood level of talampicillin reached peek level rapider than clindamycin and cefadroxil. The blood levels of the extraction wound were 60 - 80% as compared with the venous blood levels with each antimicrobial agent.

[Clinical evaluation of clarithromycin in treatment of acute dental infections. Comparative double-blind study using josamycin as the control].

In order to objectively evaluate the usefulness of clarithromycin (TE-031, A-56268), a new oral macrolide antibiotic, in the treatment of acute dental infections, a double-blind comparative clinical trail was conducted using josamycin (JM) as the control drug. TE-031 was administered at a daily dosage of 400 mg in 2 divided doses, and JM was given at a daily dosage of 1,200 mg in 3 divided doses. The administration period was, as a rule, 7 days. A total of 302 patients were administered with the test substances (TE-031 and JM), and the clinical efficacy was evaluated by investigators for 284 patients and by a committee using a score method for 273 patients. Efficacy rates as evaluated by the investigators were 77.2% (105/136) in the TE-031 group and 69.6% (103/148) in the JM group. Efficacy rates as evaluated by the committee by the score method were 86.0% (111/129) in the TE-031 group and 80.6% (116/144) in the JM group. The differences between the 2 drug groups were not statistically significant. The investigators' evaluation of the clinical efficacy in the treatment of osteitis of the jaw gave an efficacy rate of 83.0% (44/53) in the TE-031 group and 64.7% (33/51) in the JM group. The efficacy rate in the TE-031 group was statistically higher than that in the JM group. Side effects were recorded in 7 patients (4.8%) in the TE-031 group and 3 patients (2.0%) in the JM group, while abnormal laboratory test values were detected in 3 cases each in the TE-031 and JM groups. None of these differences were statistically significant. The usefulness rates ("satisfactory" plus "very satisfactory" cases) were 73.9% in the TE-031 group and 70.3% in the JM group and were thus almost the same for the 2 drug groups. On the basis of the above results, TE-031 was concluded to be a useful drug in the treatment of acute dental infections and is expected to be able to achieve almost identical clinical efficacy as JM at only one-third of the usual dosage of JM.

[Comparative clinical study of azithromycin with tosufloxacin tosilate in the treatment of acute odontogenic infection].

To objectively assess azithromycin (AZM) for its clinical efficacy, safety and usefulness in the treatment of acute odontogenic infections (periodontitis, pericoronitis and osteitis of the jaw), a double-blind, randomized, multi-center trial was conducted in which tosufloxacin tosilate (TFLX) was used as the control drug. AZM was administered to 90 patients at a once-daily 500 mg dose for 3 days, while TFLX was given to 90 patients at a 150 mg t.i.d. dose for 7 days. 1. The clinical efficacy rates calculated according to evaluation at an endpoint set on the 3rd day of treatment by a committee of experts were 85.9% (73/85) in the AZM group and 78.9% (71/90) in the TFLX group. No statistically significant difference between the treatment groups was detected, and clinical equivalence was verified (p = 0.002). 2. The clinical efficacy rates according to evaluations made by investigators at the end-of-tail point was 87.1% (74/85) in the AZM group and 73.3% (66/90) in the TFLX group. The efficacy rate in the AZM group was higher than that in the TFLX group, and the difference was statistically significant (p = 0.006). 3. The bacteriological elimination rate in the AZM group was 97.5% (39/40) and that in the TFLX group was 85.7% (30/35), but the difference was deemed statistically not significant. 4. Adverse reactions were observed in 11 of 88 cases (12.5%) in the AZM group and 5 of 90 cases (5.6%) in the TFLX group. Six of 85 cases (7.1%) in the AZM group and 5 of 85 cases (5.9%) in the TFLX group showed laboratory abnormalities. However, neither adverse reactions nor laboratory abnormalities showed any differences in statistical significance between the treatment groups. 5. The safety rates, expressed as percentages of cases with no adverse events and no laboratory abnormalities, was 84.1% (74/88) in the AZM group and 90.0% (81/90) in the TFLX group. The difference between the two groups was found to be statistically insignificant. 6. The usefulness rates, the ratio of cases rated as either "Very useful" or "Useful", was 83.9% (73/87) in the AZM group, and it was statistically higher (p = 0.025) than 72.2% (65/90) obtained for TFLX group. Judging from the above results, it has been concluded that AZM is as useful as TFLX in the treatment of acute dental infections.

[Clinical evaluation of roxithromycin in odontogenic infection].

The clinical effectiveness and safety of roxithromycin (RU 28965, RU), a new macrolide antibiotic, were compared with those of josamycin (JM) using a double-blind method in the treatment of orofacial odontogenic infections. The diseases covered in this study were periodontal infections, pericoronal infections and osteitis of jaws. Drugs were administered for 3 to 7 days at daily doses of 300 mg (RU) and 1,200 mg (JM). A total of 270 cases was evaluated in this study. Results obtained are summarized as follows: 1. The clinical efficacy was evaluated through the judgement of doctors in charge of 247 cases (128 in the RU group and 119 in the JM group) and by a committee on the 3rd day of treatment in 243 cases (126 in the RU group and 117 in the JM group). Clinical efficacy rates according to the committee judgement were 78.6% for the RU group and 82.1% for the JM group. As for the evaluation through the doctors' judgement, they were 79.7% for the RU group and 73.1% for the JM group. There was no significant difference in clinical effectiveness between 2 groups according to these 2 methods of judgement. 2. Some side effects were observed in 4 cases (2.9% out of 136) treated with RU and in 3 cases (2.4% out of 126) treated with JM. No severe symptoms were observed. Abnormal changes in laboratory test values were noted among 7.9% in the RU group and 4.0% in the JM group. There were no significant differences in their safety between the 2 groups. 3. In terms of clinical usefulness, there were no significant differences between the 2 groups as well. From these results, it has been concluded that RU (daily dose 300 mg) is as effective as JM (daily dose 1,200 mg) in the treatment of orofacial odontogenic infections.

[A comparative double blind study of lenampicillin and talampicillin in the treatment of oral infections].

A comparative double blind study of lenampicillin (LAPC, KBT-1585) and talampicillin (TAPC) was carried out in order to objectively evaluate efficacy, safety and utility of LAPC in treatment of 238 patients with oral infections. Cases accepted by the Central Committee for evaluation of efficacy and utility were 218, consisting of 101 of the LAPC group and 117 of the TAPC group; safety were 234, consisting of 110 of LAPC and 124 of TAPC. Clinical effectiveness as rated by attending doctor was 84.2% for the LAPC group and 82.9% for the TAPC group. The clinical utility rating was 82.2% in the LAPC group and 82.1% in the TAPC group, showing no significant difference between the 2 drugs. Adverse reactions were found in 6 cases (5.5%) in the LAPC group and 5 cases (4.0%) in the TAPC group, showing no significant difference between the 2 drugs. Cases accepted by the controllers for evaluation of efficacy and utility were 236, consisting of 111 cases of LAPC and 125 cases of TAPC. Those for safety were 236, consisting of 111 cases of LAPC and 125 of TAPC. The clinical effectiveness rating was 77.5% in the LAPC group and 79.2% in the TAPC group. Clinical utility rating was 75.7% in the LAPC group and 78.4% in the TAPC group. Rate of adverse reactions was 5.4% in the LAPC group and 4.0% in the TAPC group, showing no significant difference between the 2 drugs. Cases evaluated for efficacy according to numerical rating on the 3rd day were 200 cases, consisting of 93 of LAPC and 107 of TAPC. The effectiveness rate was 83.9% in the LAPC group and 95.3 in the TAPC group, showing a significant difference between the 2 drugs. On the other hand, taking into consideration evaluation scores of the 5th day, the effectiveness rate was 88.7% in the LAPC group and 96.1% in the TAPC group, showing no significant difference between the 2 drugs. The effectiveness rate in cases of isolated organisms was 84.9% in the LAPC group and 79.7% in the TAPC group, showing no significant difference between the 2 drugs. Adverse reactions were mostly of gastrointestinal origin. Symptoms were not serious and disappeared soon after administration was discontinued or immediately after administration was completed.(ABSTRACT TRUNCATED AT 400 WORDS)

[Clinical evaluation of lenampicillin in oral and maxillofacial infections].

Clinical efficacies of newly developed synthetic oral ampicillin prodrug lenampicillin (LAPC, KBT-1585) applied to 109 cases of oral infection were studied. There were 7 dropout cases. The results as determined on a point system are as follow: Remarkably effective, 26 cases; effective, 63 cases; and not effective, 13 cases, for an efficacy rate of 87.3%. When rated by the subjective judgement of the doctors in charge, these figures are as follow: remarkably effective, 21 cases, effective, 67 cases; slightly effective, 10 cases; and not effective, 4 cases. The rate of efficacy in this way being 86.3%. In either way, the results obtained were favorable. Among 102 cases in this study, pus was aspirated with sterile needle from obstructed abscesses in 65 cases, with the result that 161 strains of bacteria were isolated and identified. Most of infections were found mixed type by aerobic Gram-positive cocci and anaerobes. Especially, cases caused by alpha-Streptococcus were observed in 48 out of 55 mixed infective cases. LAPC's MIC distribution against the detected bacteria showed strong antibacterial effect as follows: against Gram-positive cocci, less than 0.39 micrograms/ml; against Gram-negative bacteria (excluding some insusceptible strains), less than 3.13 micrograms/ml. Thus, LAPC demonstrated a superiority when compared to CEX by 4 approximately 128-fold, and when compared to AMPC by about 2-fold. Adverse reactions among the 109 cases consisted of 6 cases of gastro-intestinal disorders including 3 cases of diarrhea. Recognized cases of abnormal laboratory findings were 3 cases out of 76 (3.9%), but none were serious.

Electrochemical bacteriocidal action based on electron transfer of salivary bacteria.

Based upon the observation that most oral bacteria are negatively charged, we attempted to restrain the development of oral bacteria in saliva by applying a constant electric potential to an electrode. The development of salivary bacteria was clearly restrained by applying 0.74V electric current for 30 min. This restraint was in inverse proportion to the concentration of the suspension of salivary bacteria. The authors hypothesize that the electrochemical restraining was based on electron transfer between the salivary bacteria and the electrode.